The following data is part of a premarket notification filed by International Medsurg Connection, Inc. with the FDA for Under Buttocks Drape.
| Device ID | K042893 |
| 510k Number | K042893 |
| Device Name: | UNDER BUTTOCKS DRAPE |
| Classification | Drape, Surgical |
| Applicant | INTERNATIONAL MEDSURG CONNECTION, INC. PO BOX 100624 Cudahy, WI 53110 |
| Contact | Teodoro Santiago |
| Correspondent | Teodoro Santiago INTERNATIONAL MEDSURG CONNECTION, INC. PO BOX 100624 Cudahy, WI 53110 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-19 |
| Decision Date | 2005-03-11 |
| Summary: | summary |